PROJECT LEADER - ASIAN BIOTECHNOLOGY, PHARMACEUTICALS, MEDICAL EQUIPMENT AND REGULATION

LEO KURNIAWAN
Asian Pharmaceuticals, Medical Devices, Drug Regulation
Leo served as Medical and Regulatory Director in several MNCs like Merck Asian (1979 - 1983); Sandoz Asian (1983 - 1986); Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson (1986 - 1996); Upjohn Asian (1996 - 2000); Pharmacia Upjohn Asian (2000 - 2003); and Sanofi Pasteur Asian, the Vaccines Division of Sanofi Aventis International (2003 - 2012). Leo has experiences in new products registration, extension of Marketing Authorization for existing products, and medical devices. He has experiences in GCP training and GMP training, and in negotiating with the Asian Regulatory Authority and Ministry of Health regarding clinical studies, biological samples transferring, export and intellectual property.